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Growth Hormone Dynamics and Cardiac Steatosis in HIV

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ClinicalTrials.gov Identifier: NCT03826160
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date January 30, 2019
First Posted Date February 1, 2019
Last Update Posted Date August 14, 2019
Actual Study Start Date January 30, 2019
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 30, 2019)
Intramyocardial lipid content [ Time Frame: 6 months ]
Measure of fat content within cardiac muscle as assessed by cardiac magnetic resonance spectroscopy (MRS)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 30, 2019)
Circumferential diastolic strain rate [ Time Frame: 6 months ]
Measure of diastolic function as assessed by cardiac magnetic resonance imaging (MRI)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Growth Hormone Dynamics and Cardiac Steatosis in HIV
Official Title Role of Growth Hormone in the Pathogenesis and Treatment of Cardiac Steatosis and Diastolic Dysfunction in HIV
Brief Summary Cardiac steatosis is increased among individuals with HIV, and may predispose to cardiac mechanical dysfunction and subsequent heart failure. The pathogenesis and treatment of cardiac steatosis is not well understood. The investigators have previously shown that perturbed growth hormone (GH) secretion in HIV contributes to ectopic fat accumulation in the viscera and the liver. Moreover, the investigators have found that augmentation of endogenous GH secretion with the FDA-approved medication tesamorelin reduces visceral and hepatic fat. In this longitudinal observational study, the investigators will examine patients with HIV and abdominal fat accumulation who either plan or do not plan to initiate tesamorelin prescribed clinically. The investigators hypothesize that blunted GH secretion in HIV is associated with cardiac steatosis. The investigators also hypothesize that use of tesamorelin for 6 months is associated with a reduction in intramyocardial fat and preserved cardiac function.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood samples for subsequent processing
Sampling Method Non-Probability Sample
Study Population HIV patients, age 40-70 years old, with abdominal fat accumulation
Condition
  • Human Immunodeficiency Virus
  • Lipodystrophy
  • Cardiac Disease
Intervention Not Provided
Study Groups/Cohorts
  • Tesamorelin
    Individuals who plan to initiate tesamorelin clinically
  • No Treatment
    Individuals who decline to initiate tesamorelin despite a clinical indication
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 30, 2019)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 30, 2021
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Men and women, ages 40-70 years
  • Documented HIV infection on stable antiretroviral therapy for ≥ 3 months
  • Abdominal obesity with waist circumference ≥ 102 cm in men, ≥ 88 cm in women
  • Indication for tesamorelin per clinical judgment

Exclusion Criteria:

  • CD4 < 100 cells/mm3 or HIV viral load > 400 copies/mL
  • Current active AIDS-defining illness
  • History or symptoms consistent with heart failure
  • Standard contraindications to MRI including severe allergy to gadolinium
  • Glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2 within one month of MRI study
  • Use of growth hormone-releasing hormone (GHRH) or growth hormone (GH) within the past 6 months
  • HbA1c > 7%, chronic insulin use within the past 6 months, and/or change in anti-diabetic agents within the past 3 months
  • Change in statin therapy within the past 3 months
  • Chronic corticosteroid use except intermittent topic steroid creams or inhalers
  • Pregnancy or breastfeeding
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Lindsay T Fourman, MD 617-643-4590 lfourman@partners.org
Contact: Steven Grinspoon, MD 617-724-9109 sgrinspoon@mgh.harvard.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03826160
Other Study ID Numbers 2018P001792
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Steven K. Grinspoon, MD, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date August 2019